Consumer groups back FDA on NDI draft guidance

For immediate release: February 3, 2021

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org(412) 945-3242 or Taun Sterling, tauns@nclnet.org(202) 207-2832

Washington, DC—While the Biden Administration reviews late-hour regulations enacted by the Trump Administration, one important FDA guidance related to CBD deserves further consideration. The U.S. Food and Drug Administration recently withdrew its pending CBD guidance, which the agency had submitted last summer. These highly anticipated guidelines were meant to elaborate on FDA’s CBD enforcement policy as unregulated, untested CBD products continue to infiltrate the consumer market. The FDA has not yet shared a timeline for re-submitting the CBD guidance.

NCL launched Consumers for Safe CBD in 2019 to encourage the FDA to use its existing authority to curtail the proliferation of potentially dangerous, unapproved CBD products and to incentivize CBD research, clinical trials, and the creation of science-based CBD medicines.

NCL Executive Director Sally Greenberg released the following statement in response to the FDA pulling its guidance:

The early weeks of 2021 have brought about many changes – with a new Administration, a new Congress, and continued progress in the fight against COVID-19,  there is hope for a safer, healthier future. NCL will continue to do its part to protect consumers and promote public health.

Unfortunately, CBD manufacturers continue to make unsubstantiated medical claims about their products, putting consumers at risk. We remain hopeful that the FDA and the Biden Administration will join us in our efforts to protect consumers from the potential dangers that exist in the current unregulated, wild west CBD marketplace.

NCL urges the FDA to re-circulate an updated proposal that encourages further research into CBD and the development of science-based CBD medicines and uses the FDA’s authority to regulate the CBD marketplace to protect consumers from CBD products that may put them at risk. Consumers deserve a safer, healthier future. We simply cannot abandon this work now.

To learn more about NCL’s Consumers for Safe CBD campaign, click here. To learn more about FDA’s recent efforts related to CBD, click here.

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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Welcoming FDA’s call for better science, more research on CBD

In 2019, in response to the growing retail market of untested, unapproved cannabidiol (CBD) products, NCL identified the need for greater consumer education and increased regulation at the federal level. NCL and its partners — Consumer Federation of America and the Community Anti-Drug Coalitions of America — created Consumers for Safe CBD to help raise awareness of the unregulated CBD marketplace, champion the rights of consumers, and call on government and industry to do more to protect consumers. This year, we will continue to work with key stakeholders to encourage safe CBD food and beverage products and promote a pathway for new therapeutic products through clinically-tested scientific research.

We’ve come a long way since our launch, and FDA is making progress. Newly former FDA Commissioner Stephen Hahn and Principal Deputy Commissioner Amy Abernethy recently called for better science, more data, and increased testing to determine the risks and benefits associated with CBD. We are encouraged by the commitments outlined in the FDA statement and look forward to continued collaboration with the Biden Administration and the new leadership at the agency to make the CBD marketplace fair, safe, and healthy for consumers.

Read more about the FDA’s comments on the Consumers for Safe CBD here and sign up for CBD updates from our Consumers for Safe CBD campaign here.

NCL concerned Congress seeks to approve unreviewed CDB products

Sept. 17, 2020

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC—On September 4, lawmakers introduced The Hemp and Hemp-derived CBD Consumer Protection and Market Stabilization Act of 2020 (HR 8179), which directs the U.S. Food and Drug Administration (FDA) to make hemp and hemp-derived CBD lawful as a dietary ingredient or dietary supplement. The National Consumers League (NCL) has long been concerned about the public health and safety risks posed by unapproved cannabis-derived products. NCL does not support legislation that seeks to bypass FDA’s authority and circumvent the scientific rigor of an FDA review.

Under current law, manufacturers and distributers of CBD products can already petition the FDA to review and approve a new ingredient for use as a dietary supplement (21 U.S.C. 350b). For FDA approval as a dietary supplement or new ingredient, manufacturers and distributors are required to submit scientific data, including any published studies, to provide a basis to conclude that a product is generally regarded as safe (GRAS). Unfortunately, there is a disconcerting lack of research and data about the safety of CBD products already in the market, whereby millions of consumers are using to self-treat serious and life-threatening ailments.

In response to the proliferation of unreviewed and untested CBD products in the market, NCL launched the Consumers for Safe CBD program to provide greater education to consumers about CBD. As demonstrated in a white paper published by NCL, cannabis companies tend to focus their research efforts on inexpensive, low-strength studies that are ultimately used for marketing purposes, not to enhance scientific knowledge or bring new proven therapies to patients. HR 1879 would further incentivize CBD manufacturers to forego the more rigorous and costly clinical trial process for developing an FDA-approved medicine.

NCL is concerned that CBD manufacturers and distributers making claims to treat certain medical issues will seek expedited approval of CBD products as a dietary supplement, instead of as a drug. Lawmakers should encourage the development of cannabis-based medicines that have undergone the rigor of randomized controlled clinical trials to learn more about how cannabis-derived therapies can both help and harm patients. This legislation seeks to fast-track the classification of CBD products as dietary supplements or ingredients without sufficient scientific data on their safety and efficacy, potentially placing consumers further at risk.

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Consumers for Safe CBD is working to protect, educate Americans

As America’s premier consumer advocacy organization, with a rich history of fighting to make the marketplace fair, safe, and healthy for consumers, NCL is hard at work on the most important issues in food and drug safety and to collaborate on improving consumer education.

In recent years, NCL has been observing the CBD, or cannabidiol, marketplace exploding, with products lining shelves of grocery stores, specialty shops—even gas stations. Products were appearing to make many claims or hint at miracle cures, and most consumers had no idea how or whether the products were being regulated. Who is making sure these tinctures, oils, gummies, and lotions are safe, and do they do what they claim?

This is why last year, NCL joined forces with the Consumer Federation of America and the Community Anti-Drug Coalitions of America, to create a national campaign called Consumers for Safe CBD.

NCL had identified a serious need for greater education among consumers about CBD, and that’s why Consumers for Safe CBD was created. Consumers for Safe CBD aims to help educate the public about the risks related to untested, unapproved CBD products on the market, champion the rights of consumers, and call on the U.S. Food and Drug Administration (FDA) and industry to do better to ensure safety and promote a pathway for new products through clinically tested scientific research.

“Cannabidiol, commonly referred to as CBD, is being used in a growing number of consumer products and is illegally sold in stores and on the Internet,” said NCL Executive Director Sally Greenberg. “We’re working to educate consumers and ensure accurate labeling, clear guidelines, and further research to protect against unknown and known risks of CBD products.”

NCL and its partners continue to raise awareness among consumers, policymakers, and regulators about the health risks associated with the unregulated CBD marketplace, in particular with the unproven health claims and often inaccurate labeling of products on the market today. Beyond the known health risks associated with unregulated CBD, there are a number of unscrupulous marketing tactics that prey on unsuspecting consumers. This includes false and dangerous claims that CBD has medical benefits that can prevent and stop the spread of the COVID-19.

By warning consumers about these false claims, participating in media interviews and publishing op-eds across the country, highlighting important research and reports, and sending letters to several retailers, state Attorneys General and Members of Congress, the campaign is working to protect consumers across the country from unapproved and potentially dangerous CBD products.

“We need to better understand the potential health benefits of CBD, but this can only be accomplished through clinical testing and scientifically validated methodologies,” said Greenberg. “We need the FDA to step up for consumers and for the public health.”

The time for action is now. CLICK HERE for more information about the Consumers for Safe CBD effort.

Sorting through bogus health claims

Across the United States, people are rising to the historic health needs and challenges posed by coronavirus, with healthcare workers on the frontlines risking their lives, and businesses pivoting to manufacture much-needed medical and protective supplies.

But deep concerns about the health implications—what happens to people who contract the disease from a health and financial perspective—are top of mind for many of us. And a cynical minority has seized on the crisis to employ unscrupulous, and frankly dangerous, marketing tactics to promote bogus products claiming to protect users against the coronavirus or provide relief for those infected—as well as peddling downright phony coronavirus testing products.

“These false claims touting unproven medical benefits are nothing more than craven attempts to take advantage of fearful consumers,” said NCL Executive Director Sally Greenberg.

“Moreover, they spread misinformation among consumers anxiously seeking ways to stay safe and healthy amidst the coronavirus crisis.”

In an op-ed in The Hill published in May, Greenberg noted that a number of CBD manufacturers and stores are falsely promoting unproven medical benefits of CBD products.

A CBD store in Portland, OR, for example, was recently ordered by the office of the state’s attorney general to take down signs claiming that its products could boost immunity against COVID-19.

“False claims such as this are particularly dangerous as consumers anxiously attempt to stay safe and healthy amidst the coronavirus crisis,” said Greenberg. “The need for science-backed treatments is significant and we must ensure products are tested and regulated for safety.”

Contrary to claims being made by CBD marketers that products containing cannabidiol can help those suffering from coronavirus, recent studies have actually found potential harmful side effects of cannabis products on infected coronavirus patients. Aurelius Data cautions the public against the potential harmful side effects that can come from consuming cannabis products with Tetrahydrocannabinol (THC) if a patient is infected with COVID-19. And studies have shown that many unregulated CBD products have been found to contain THC, though the labels may not disclose this.

“In these uncertain times, we urge consumers to continue to take precautions,” said Greenberg. “We urge everyone to follow CDC guidelines for COVID-19, practice safe social distancing, and at the same time avoid THC products and all untested, unregulated CBD products to help keep your family, friends, and communities safe.”

Fighting for crucial consumer, worker protections and fair outcomes in coronavirus environment

March 27, 2020: A message to our online community about how we are working hard to ensure crucial protections for consumers and workers in this time of uncertainty.

Sally Greenberg discussing CBD on Capitol Hill

Coronavirus update: Fighting for crucial protections, fair outcomes

A message to our online community

In this critical time, as our nation is gripped by the COVID-19 virus, we want you to know that we remain 100% committed to doing everything we can to help stop the spread of the virus and to fight for consumer and worker protections in this rapidly changing economy.

Although we are now doing so remotely in order to maintain our safety and the safety of our loved ones, NCL staff continues to work behind the scenes to ensure that the interests of consumers and workers are not forgotten in the rush to pass legislation and make executive branch decisions.

Below we’ve highlighted what’s happening and hope that you agree that our work – and your support – are more important than ever.

Pushing Congress to protect passengers in COVID-19 relief legislation

The pandemic has reduced passenger air traffic to a trickle, putting the airlines in deep economic distress. A strong, well-functioning, and safe airline industry is essential to our country. That said, NCL does not believe that giving a blank check to the industry is in consumers’ best interest. That’s why NCL led a coalition of consumer and air passenger advocates to call on Congress to include strong passenger protections in the COVID-19 relief bill. We will continue to advocate for reforms to the airline’s business practices, like excessive fees and shrinking seats, in the weeks and months to come.

Fighting COVID-19 scams

We are actively reaching out to consumers to educate them about how to spot coronavirus-related scams. We are already seeing reports of scammers using this moment of national emergency to sell bogus coronavirus “cures” and target seniors with phony investment scams. That’s why we issued a statement applauding Attorney General William Barr’s order to all U.S. Attorneys to ramp up efforts to shut down COVID-19 scams and are continuing to alert our readers about emerging trends.

We are also using our Consumers for Safe CBD platform (4safeCBD.org) to highlight false product claims made by unscrupulous CBD manufacturers who are using the crisis to promote their products .

Healthcare in the new environment

In response to a request for help from FDA, NCL is supporting the agency’s efforts to expose bogus coronavirus tests, treatments, and cures. In addition, we signed onto a letter as part of our adult vaccine coalition to ask for ZERO CO-PAYs for all Medicare Part D vaccines, which could include COVID-19 vaccines when they become available. With safety as a paramount concern, NCL is supporting the American Nurses Association’s call to action to increase Personal Protective Equipment (PPE) for nurses.

Crucial worker protections

NCL persists in its fight for worker protections and joined a letter opposing the exclusion of immigrants from the omnibus relief package. We also signed onto an effort to ensure the Postal Service can remain fully functional during this crisis and beyond. The USPS is predicting that an economic recession could pose a “serious threat to the near-term viability of the Postal Service,” and has asked Congress to give USPS more than $7 billion each year for the next two years.

NCL joined allies at farmworker organizations in expressing concerns related to exposure of the largely uninsured, financially fragile farmworker community to COVID-19 and asking political leaders to be mindful of the unique concerns, considerations, and risks confronting farmworkers.

Looking ahead

NCL remains actively engaged in working to properly ensure that relief packages address the interests of consumers and workers. We are very pleased that Congress will be providing cash assistance to our most vulnerable, and we continue to push for salary and benefit protections, particularly for those workers in the most seriously impacted industries.

In the coming days, stay tuned for news of our Trumpeter Awards Dinner, which we will host in October. We will be sending out a Save the Date and announcing our award recipients shortly.

Best wishes for staying safe and healthy, from all of us at NCL.

Sally Greenberg
Executive Director
National Consumers League

NCL: #NeverMoreRelevant

Capitol Hill briefing alerts lawmakers to public health ramifications of CBD proliferation

Lawmakers need to be aware of the threats to public health posed by the proliferation of unregulated, untested CBD products currently widely available in the marketplace. There is a great deal of work to be done in Washington to better understand the healing potential of CBD, while also protecting consumers from the dangers of what is currently an anything-goes market environment.

That was the compelling message participants took from a congressional staff briefing last week on “The Future of Cannabis as a Drug.” Expert speakers, including National Consumers League Executive Director Sally Greenberg, issued a two-pronged call for action: to intensify clinical research into new medical treatments containing CBD, while encouraging the Food and Drug Administration (FDA) to proactively regulate non-medical, over-the-counter CBD products that are frequently mislabeled and contain potentially harmful ingredients.

The briefing featured opening remarks by U.S. Representatives Scott Peters (D-CA) and Cathy McMorris Rodgers (R-WA) and was moderated by Ron Manderscheid, Executive Director of the National Association of County Behavioral Health and Developmental Disability Directors and the National Association for Rural Mental Health. “We would like to have more understanding and more confidence in CBD products,” Rep. Peters explained. “You should know what you’re getting”.

Attendees received eye-opening data about the ways in which readily-available CBD products—sold in the form of oils, lotions, food additives, and more—have the potential to make consumers ill. Few realize, for example, that an independent study found 70 percent of the top-selling CBD products contain substances such as pesticides, arsenic, and toxic mold.

NCL’s Greenberg previewed upcoming academic research that will place a spotlight on the questionable science being utilized by CBD and cannabis companies, often in partnership with academia, to lend legitimacy to these products and short-cut the regulatory approval process. “Not only are these products untested, but they are inaccurately labeled,” said Greenberg. “We want FDA to do what it’s supposed to do, and what we as consumers expect it to do.” 

NCL launched Consumers for Safe CBD to warn the public of the potential health and safety risks associated with unregulated and unlawfully marketed CBD products.

Susan Audino, a board member of the Center for Research on Environmental Medicine in Maryland, shared her findings on the lack of quality controls currently in the CBD marketplace and how product marketing is accelerating faster than the science used to substantiate claims of enhanced health and well-being. “We even trust McDonald’s to inform us of the number of calories in a Big Mac,” said Audino. “When it comes to cannabis, we are not afforded that same safety and assurance.”

James Werline, a pharmacist and the father of a daughter with a severe form of epilepsy, spoke to the promise and importance of CBD-related research. The only CBD medication currently approved by the FDA is used to prevent seizures caused by rare forms of childhood epilepsy. Angelique Lee-Rowley, Vice President, Global Chief Ethics and Compliance Officer at Greenwich Biosciences, discussed the importance of clinical research into new CBD treatments and shed light on the restrictions pharmaceutical companies have in educating consumers on product efficacy versus the retail and online marketers who have few boundaries in the claims they can make.

“We are on the verge of a major breakthrough,” said Rep. McMorris Rogers. “We want to be encouraging those breakthroughs. I am committed to helping with those developments.”

The briefing served to alert congressional staff to the seriousness of this issue. By 2022, the CBD marketplace is expected to reach $1.8 billion in sales, more than triple what it was just four years earlier. As the commerce expands, so do—without adequate consumer protections—the threats to health and safety.

Letter to Congress: NCL calls for safe CBD

December 10, 2019

Dear Member of Congress,

For more than 120 years, the National Consumers League has pursued the values of access to quality products, honest labeling, and safe, effective medicines for America’s consumers. We write to you today about a growing public health concern affecting millions of Americans in every state and congressional district across the country. Unregulated, untested cannabidiol (CBD), an extract of the hemp plant, has infiltrated the market in a dizzying range of products. These products pose a significant threat to consumers.
 
The CBD market is one of the fastest growing retail segments in the nation. By 2022, Americans are expected to purchase approximately $1.8 billion worth of these products, triple the amount since last year. CBD, however, continues to raise questions and concerns for consumers.
 
CBD products are not currently tested or evaluated for safety and efficacy, nor required to meet similar safety standards as the tube of toothpaste we buy at the grocery store. CBD products are too often deceptively labeled and may contain contaminants that can harm consumers. Independent testing of the 240 top-selling CBD products found that 70 percent were contaminated with substances including lead, arsenic, herbicides, pesticides, and toxic mold.
 
New public opinion research conducted by Greenberg Quinlan Rosner finds that voters overwhelmingly – an 83 percent majority – support allowing the Food and Drug Administration (FDA) to evaluate and regulate CBD products. The research found that ensuring the safety and effectiveness of CBD grows even stronger among those who have used CBD products or describe themselves as very familiar with them. When asked about illness resulting from vaping CBD, 83 percent of respondent expressed concern, with nearly half, 48 percent, being very concerned.
 
This is why NCL created Consumers for Safe CBD in partnership with Consumer Federation of America (CFA) and Community Anti-Drug Coalitions of America (CADCA) to encourage the FDA to take strong, effective, and prompt action to protect the public from the potential harms posed by unregulated, untested CBD.
 
As Executive Director of NCL, I hope you will lend your voice in calling for the FDA to take immediate action to protect consumers from potentially harmful CBD products and pursue four common-sense objectives:

1. WARN THE PUBLIC OF THE DANGERS OF THE CBD MARKET

The public should be warned regarding the dangers of unapproved, untested CBD products. Clearly, as verified by the explosive growth in sales, the public is not appropriately informed about the potential dangers of unapproved, untested CBD products that contain harmful contaminants and may not have the ingredients listed on product labels. Resources should be devoted to a national informational campaign that warns consumers of these dangers. There is a growing interest in CBD products, but the marketplace is largely an unregulated “wild west,” and consumers literally often have no way of knowing what is contained in the products they are purchasing.

2. ENFORCE EXISTING REGULATIONS REGARDING LABELING (INGREDIENTS, RISKS, ETC.)

The FDA should curtail the proliferation of potentially dangerous, unapproved CBD products by using its existing legal authority. The FDA should use its authority to penalize manufacturers, marketers, and distributors of CBD products that: 1) make medical claims that cannot be scientifically verified, 2) market products to minors, 3) sell products that contain higher or lower-than-advertised levels of CBD and/or THC, or harmful ingredients and 4) sell products that have inaccurate labels. Swift and strong enforcement can serve as an effective deterrent effect against the future marketing of unapproved, potentially harmful CBD products.

3. DETERMINE SAFE LEVELS OF THC/CBD TO BE ALLOWED IN CBD PRODUCTS

Clear differentiation between medicines and consumer products should be established, including firm parameters as to CBD levels that can be safely included in a particular product. The FDA should establish a firm, enforceable ceiling on the potency of CBD that can be contained in an individual product and require safe packaging practices, similar to the child-proof cap closures on prescription medicines. All products should include a 1-800 phone number to allow concerned consumers to call the manufacturer to make specific inquiries about the product.

4. ENCOURAGE ROBUST CLINICAL RESEARCH INTO THE POTENTIAL OF CBD TO IMPROVE HEALTH AND LIVES

The FDA should incentivize CBD research, clinical trials, and the creation of new CBD treatments that are thoroughly vetted through the proven FDA process. CBD has the potential to improve lives, but with little research and clinical data, the risk is currently greater than the reward. We should encourage research to ensure that CBD reaches its full potential. 
 
Your constituents should be protected from the potential dangers related to CBD products. This does not require the creation of new laws or regulations, but rather that the FDA simply use its existing authority to protect public safety. The agency has already sent more than 50 warning letters to CBD product manufacturers making egregious health claims about their products’ ability to treat cancer and other serious illnesses. It recently advised women who are pregnant or breastfeeding to avoid using any CBD products, citing a number of health and safety risks. But these efforts need to be stepped up. We hope you will join us in asking the FDA to erect stronger safeguards, including safe concentration limits, around a rapidly growing, but unregulated, industry that is already causing harm to consumers.
 
If you or your staff has any questions, please reach out to our Director of Health Policy Patricia Kelmar at patriciak@nclnet.org or 202-207-2824.
 
Thank you for your consideration.

Sally Greenberg
Executive Director
National Consumers League

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

National Consumers League statement on FDA action regarding CBD

November 29, 2019

Leading consumer advocate urges ‘buyer beware’ as busiest shopping season of the year gets underway

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC—Sally Greenberg, executive director of the National Consumers League and a convening partner of Consumers for Safe CBD, today released the following statement in response to FDA’s recent action regarding CBD:

“The decision by the FDA to send 15 new warning letters and remind consumers of potential harm caused by untested and illegal CBD is a step forward in keeping millions of Americans safe. While regular communication from the FDA is helpful, it’s critical that we pursue tangible actions that will lead to broad awareness and prevent the sale of harmful CBD products in a marketplace that is growing by the day. This includes enforcing existing regulations regarding labeling and ingredients, as well as setting safe concentration levels. We cannot wake up a year from now and wish that we had done something when there are practical and achievable solutions right in front of us. Our recent polling shows that 83 percent of registered voters support regulating CBD. We need the gold standard that the FDA provides now more than ever.

“Today marks the start of the busiest shopping season of the year. As consumers head to stores and browse the Internet for deals, we are urging buyer beware when it comes to CBD products. The risk of not getting what you pay for and, even worse, putting one’s own health in jeopardy is far too great. Until the FDA steps in with its stamp of approval, we have no choice but to warn consumers to avoid unregulated CBD products and encourage family and friends to do the same.

“The National Consumers League and Consumers for Safe CBD will continue to work with advocates, policymakers and other stakeholders to ensure that we keep people safe, provide a much-needed sense of clarity and put the interests of the consumer first.”

Learn more about the CBD Myths and Facts HERE.

Learn more about what could be in CBD products HERE.

See what others are saying about CBD HERE.

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.